This study evaluates whether a single dose of anrikefon, given intravenously shortly before the end of kidney stone removal surgery (PCNL), can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. All participants receive the same standard pain control regimen (flurbiprofen axetil plus a sufentanil patient-controlled pump). In addition, half receive anrikefon and half receive a placebo (saline), decided by random allocation, with neither patients nor doctors knowing who receives which. A total of 160 adults (18-75 years) undergoing elective PCNL at Beijing Tsinghua Changgung Hospital will take part. Pain scores, opioid use, recovery, satisfaction, kidney function and side effects will be followed for up to 3 days after surgery.
Age 18-75 years, either sex
Scheduled elective unilateral percutaneous nephrolithotomy (PCNL) under general anesthesia (stone diameter >2 cm, meeting PCNL indications)
ASA classification I-III
Body mass index (BMI) 18-35 kg/m2
Allergy to anrikefon, sufentanil, flurbiprofen axetil or their excipients
Use of opioids, NSAIDs, glucocorticoids or other analgesics within 7 days before surgery
Renal dysfunction (eGFR <60 mL/min/1.73 m2) or severe hepatic dysfunction (ALT/AST >3 times upper limit of normal)
Severe cardiovascular or respiratory disease (e.g., COPD, respiratory failure)
Parallel
0.9% Sodium Chloride Injection as Placebo
Drug5 mL IV, administered 15-30 min before the end of surgery; identical in appearance to anrikefon; used as placebo comparator.
Anrikefon
DrugSingle IV dose of anrikefon 0.1 mg diluted to 5 mL with 0.9% saline, administered 15-30 min before the end of surgery.
Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery
Cumulative sufentanil consumption
Pain intensity by numeric rating scale (NRS), 0-10 score
Total and effective patient-controlled analgesia (PCA) bolus counts (number)
PCA effective bolus ratio (%)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
